FDA UDI
In Commercial Distribution
🇺🇸 United States
Metapex Plus 2.2
DI: 08806387894797
·
Model: 9479
·
Meta Biomed Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Metapex Plus 2.2
- Primary DI
- 08806387894797
- Version / Model
- 9479
- Company Name
- Meta Biomed Co., Ltd.
- Labeler DUNS
- 688322841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-16
- Public Version
- 3
- Public Version Date
- 2023-04-13
- Public Version Status
- Update
- Public Device Record Key
- bac20ac1-5135-4baf-ae65-7650e154ada3
Device Description
This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide.The state of the treatment can be confirmed by the radiopacity of iodoform contained.Metapex Plus is used for patients of all ages requiring root canal treatment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIF | Resin, Root Canal Filling | Dental | 872.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60275 | Endodontic temporary cement | A viscous material intended to be applied to a prepared root canal to maintain its relative sterility between procedures and to facilitate its healing. It is intended to be placed within the root canal temporarily and sealed with a temporary filling material to prevent repopulation of the canal by bacteria. It is typically a zinc or calcium cement-based material that includes an antimicrobial agent (e.g., pharmaceutical or pH), and sometimes an anti-inflammatory agent, available in a tube or syringe. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806387894797 | GS1 |